(340 days)
The NGT is intended for gastric decompression, gastric suction, administration of nutritional supplements and medication, and to monitor core temperature.
The NGT Nasogastric Tube is made of a plastic material, contains three lumens, a main suction lumen, a smaller vent lumen, and a still smaller temperature thermistor lumen. The primary suction lumen is used for drainage, the second vent lumen provides an air inlet as a mechanism to break suction minimizing the potential for tube blockage secondary to mucosal tissue invagination into the side holes of the primary lumen. The device is intended to be used with a standard suction source to facilitate drainage.
The provided 510(k) summary for K022558 focuses on demonstrating substantial equivalence of the NGT Nasogastric Thermistor device to predicate devices. It states that "Bench testing was performed on the NGT to demonstrate equivalency." However, the summary does not provide any specific acceptance criteria or detailed results of this performance testing.
Therefore, I cannot populate the table or answer most of the questions as the required information is not available in the given text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| NOT PROVIDED | NOT PROVIDED |
| No specific performance metrics, thresholds, or results are mentioned in the document. | The document only states "Bench testing was performed... to demonstrate equivalency," without detailing what equivalency entailed in terms of specific performance measures. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not provided.
- Data provenance: Not provided (the document only mentions "Bench testing," which implies laboratory-based testing, but no details on data origin or type are given).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a medical tube with a temperature sensor, not an AI/Software as a Medical Device (SaMD) requiring expert-established ground truth for interpretation of images or other complex data. The document describes bench testing for equivalency, not a study involving expert review of results.
4. Adjudication method for the test set:
- Not applicable. (See answer to #3)
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/SaMD device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the conventional sense for a physical device. For "bench testing," ground truth would typically refer to known physical properties, measurements from calibrated reference instruments, or specified performance standards for gastric suction and temperature sensing. The document does not specify these.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. (See answer to #8)
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.